mHealth Cardiac Rehabilitation for INOCA

This study is testing a mobile health cardiac rehabilitation (mHealth-CR) program for people with Ischemia with Non-Obstructive Coronary Arteries (INOCA), a condition where you have symptoms of heart ischemia (reduced blood flow to the heart) but no major blockages in your heart arteries. The mHealth-CR program includes a personalized exercise plan with weekly phone calls from an exercise therapist, a mobile app to track your exercise and view educational materials, and a Fitbit Charge 5 to monitor your activity. Researchers want to see if this program improves your health over 3 and 12 months, specifically looking at changes in your angina (chest pain) symptoms. You can join if you are 18 or older and have been diagnosed with INOCA. The study is currently unclear on its recruitment status.

Study design
This is a Phase 2 randomized study involving 250 participants. You would be randomly assigned to either receive the mHealth-CR program or usual care.
What's involved
The study intervention lasts for 3 months, during which you would communicate weekly with an exercise therapist and use the mHealth-CR software and Fitbit device.
Compensation
Not stated in the trial record.
Follow-up
Your angina symptoms will be checked at 3 months and 12 months after starting the study.

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NCT06829160

mHealth-CArdiac REhabilitation for INOCA

Recruiting
NAAges 18+InterventionalTreatment
NYU Langone Health
~250 participants
Updated 2026-04-23 on ClinicalTrials.gov
What's tested:Communication with exercise therapistmHealth-CRWearable activity monitoring device

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in Seattle Angina Questionnaire (SAQ) score
Measured over Baseline, Month 3
+2 more outcomes measured
Ischemia
1 sites across 1 states
New York1
  • Harmony Reynolds, MD · PRINCIPAL_INVESTIGATOR · NYU Langone Health

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Age 18 and over
Diagnosis of Ischemia with Non-Obstructive Coronary Arteries (INOCA) based on evidence of ischemia and/or ischemic symptoms, plus non-obstructive Coronary artery disease (CAD) on computed tomography (CT) or invasive angiography

Exclusion

Seattle Angina Questionnaire (SAQ) = 100
Non-ambulatory
Pregnant
Moderate or severe cognitive impairment
Unable/willing to provide consent
Incarcerated
Unable to use mHealth
Severe osteoarthritis or joint replacement within 3 months
Parkinsons disease or other movement disorders
Regular use of walker
Life expectancy \< 12 months
Clinical judgement concerning other safety or non-adherence issues
Unable to read and communicate in English since the app content is currently only available in English.
  • Change in Seattle Angina Questionnaire (SAQ) scoreBaseline, Month 3

    The SAQ measures disease-related health status (functional status and quality of life) and has a four-week recall period. The SAQ generates a summary score (scale 0-100, 100 = full health, 0 = worst health).

  • Change in Seattle Angina Questionnaire (SAQ) scoreBaseline, Month 12

    The SAQ measures disease-related health status (functional status and quality of life) and has a four-week recall period. The SAQ generates a summary score (scale 0-100, 100 = full health, 0 = worst health).

  • Weekly percent completion of the mHealth-CR programMonth 3

    Weekly engagement will be measured as the fraction of the following elements completed each week: exercise therapy-directed activities, daily entry of exercise data and rated perceived exertion (RPE); completed weekly phone call with exercise therapist; at least one communication with exercise therapist (outside weekly phone call); reviewing educational video/text (which will vary by week). Competition will be assessed as a pseudo-continuous outcome, as the score can range from 0% (0 activities completed) to 100% (all activities completed) incorporating values for each activity.